POS0565 TOLERABILITY AND SAFETY OF RECOMBINANT ZOSTER VACCINE IN PATIENTS WITH INFLAMMATORY RHEUMATIC MUSCULOSKELETAL DISEASES - A PROSPECTIVE LONGITUDINAL STUDY OVER 6 MONTHS
Authors: I. Andreica, S. Reale, G. Intini, B. Wilde, D. Kiefer, P. Sewerin, H. Kavruk, D. Karagkiozidou, B. Guminski, A. Kribben, X. Baraliakos, J. Braun, U. Kiltz
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Herpes zoster (HZ) is common in the elderly with a lifetime risk of 25% (1). The primary risk factors for HZ are advanced age and immunosuppression. The recombinant zoster vaccine (RZV) contains recombinant glycoprotein E, the main target of CD4+T-cells. <h3>Objectives</h3> To describe the safety of RZV in patients with inflammatory rheumatic and musculoskeletal diseases (RMD). <h3>Methods</h3> Adult patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and giant cell arteritis (GCA) who had an indication to receive RZV were prospectively included. Data on demographics, vaccination, RMD diagnosis, disease activity, immunosuppressive treatments, flares, adverse events (AEs) and zoster breakthrough infections were collected at month 0, 2, 3 and 6. A flare was defined as change in ASDAS ≥ 0.9 for axSpA, change in DAS-28&gt;1.2 for RA, or clinical signs for GCA and/or CRP ≥ 0.5 mg/dl and/or ≥30 mm. Descriptive analyses were performed. <h3>Results</h3> 50 patients were included of whom 18 (36.0%) had a history of HZ (Table 1). All patients received RZV at month 0, and 49 patients also at month 2. Safety assessments were performed in 49, 48 and 36 patients in months 2, 3 and 6, respectively. A total of 62, 35, 11 AE in 38, 33, and 10 patients, respectively, were reported (Figure 1). Localized AE (n=69 (63.9%)) were far more common than generalized AE (n=28 (25.9%)). Pain at the site of injection in 46 (42.6%) patients was the most frequent AE followed by fatigue (12 (11.0%)), redness at the injection site in (9 (8.3%)), swelling at the injection site (7 (6.4%)) and fever (5 (4.6%)). Serious AEs were reported in 6 patients (2 RA, 4 GCA). None of them with causal relation to RZV. No patient reported an AE of special interest. Out of 6, 4 and 4 flares reported by patients at month 2, 3 and 6, respectively, no one fulfilled predefined flare criteria and were rated as mild to moderate. However, 3 patients (2 GCA, 1 RA) were hospitalized due to flares. No episodes of HZ occurred. <h3>Conclusion</h3> The majority of patients tolerated RZV well with only a few reports of flare and serious AEs. Majority of AEs occurred within few days after vaccination. These findings are reassuring for rheumatologists and potential vaccine recipients and support confidence in RZV safety in patients with RMD. <h3>References</h3> [1]Thomas SL, Hall AJ. What does epidemiology tell us about risk factors for herpes zoster? Lancet Infect Dis. 2004;4(1):26–33. <h3>Funding</h3> The study was funded by GSK. <h3>Disclosure of Interests</h3> Ioana Andreica Speakers bureau: Abbvie, Chugai, Novartis, UCB, MSD, Lilly, Sobi, Astrazeneca, Amgen, Pfizer, Gilead, Paid instructor for: Astrazeneca, UCB, Consultant of: Abbvie, Chugai, Novartis, UCB, Galapagos, Takeda, Astrazeneca, Lilly, Boehringer Ingelheim, Amgen, Sobi, Stefania Reale: None declared, Gianna Intini: None declared, Benjamin Wilde: None declared, David Kiefer Speakers bureau: Abbvie, BMS, Roche, Chugai, Novartis, UCB, Sanofi, MSD, Merck, GSK, Janssen, Boehringer Ingelheim, Galapagos, Consultant of: Abbvie, BMS, Roche, Chugai, Novartis, UCB, Sanofi, MSD, Merck, GSK, Janssen, Boehringer Ingelheim, Galapagos, Grant/research support from: Novartis, Philipp Sewerin: None declared, Hilal Kavruk: None declared, Dimitra Karagkiozidou: None declared, Barbara Guminski: None declared, Andreas Kribben: None declared, Xenofon Baraliakos: None declared, Jürgen Braun: None declared, Uta Kiltz Speakers bureau: Abbvie, Novartis, Janssen, Hexal, Gilead, MSD, Roche, Consultant of: Abbvie, Novartis, Lilly, Janssen, Gilead, UCB, Onkowissen, Grant/research support from: Biogen, Abbvie, Novartis, Hexal, Fresenius, Amgen.